The DAEHAN Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.

Device Description

DAEHAN Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.

AI/ML Overview

The provided text describes a 510(k) premarket notification for DAEHAN Adhesive Surface Electrodes. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is not directly available or applicable in this context for a novel device performance study.

Instead, the submission focuses on comparing the new device to a predicate device based on technical characteristics and demonstrating that the new device meets relevant performance standards.

Here's how to address your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of an adhesive surface electrode, acceptance criteria are typically defined by recognized consensus standards. The document states that the device was tested against these standards.

Acceptance Criteria (Standard)	Section	Reported Device Performance	Comments
Biocompatibility (Cytotoxicity)	ISO 10993-5	Met standard	Device evaluated for general biological safety.
Biocompatibility (Irritation & Skin Sensitization)	ISO 10993-10	Met standard	Device evaluated for general biological safety.
Electrical Property	AAMI/ANSI EC12	Met standard	Specific to "Disposable ECG Electrodes", implying electrical performance (e.g., impedance) requirements are met.
Shelf-life	ASTM F1980-02	Met standard	Evaluates the accelerated aging of sterile medical device packaging (though the device itself is non-sterile).
Electrical Safety (Patient Leads)	AAMI/ANSI ES 60601-1:2005/(R)2012, CL 8.5.2.3	Conforms to standard	Confirmed compliance with safety standards for patient leads.
Impedance	N/A (listed in comparison table)	<3KΩ	Specific technical characteristic, matching the predicate.
pH	N/A (listed in comparison table)	3.5~7.0	Specific technical characteristic, differs slightly from predicate (6.5+/-0.5) but likely within an acceptable range for intended use.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not specified for any of the non-clinical tests. These tests are typically performed on a representative sample of the devices.
Data Provenance: The tests would have been conducted by the manufacturer (Daehan Medical Systems Co., Ltd.) or a contracted lab. The country of origin for the device is the Republic of Korea. The data would be prospective, as the testing was conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This concept is not applicable here. Ground truth, in the context of device performance, is established by adherence to recognized standards and test methodologies, not expert consensus on medical images or clinical outcomes. The "experts" would be the qualified personnel performing the laboratory tests according to the standards.

4. Adjudication Method for the Test Set

Not applicable. Performance against engineering and biocompatibility standards does not typically involve an adjudication method like those used for expert consensus in clinical studies. Test results either meet the standard or they do not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reading images and improved by AI). The DAEHAN Adhesive Surface Electrodes are a non-invasive cutaneous electrode for stimulating/recording biopotential signals. Their effectiveness is demonstrated through adherence to electrical, biocompatibility, and safety standards, not through reader performance studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, standalone testing was done. The "performance testing" and "electrical safety" tests mentioned in the "Non-Clinical Test Summary" section evaluate the device itself (product performance and characteristics) against established standards without human interpretation or intervention in the diagnostic process. This is the equivalent of standalone performance for this type of device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance and safety tests is defined by the requirements and specifications within the referenced consensus standards (e.g., ISO 10993-5, ISO 10993-10, AAMI/ANSI EC12, ASTM F1980-02, AAMI/ANSI ES 60601-1). These standards establish objective criteria for what constitutes acceptable performance and safety.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI algorithms that require a "training set." The device is a hardware component (an electrode).

9. How the Ground Truth for the Training Set was Established

Not applicable. As a hardware device, there is no training set or ground truth established in this manner.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2018

Daehan Medical Systems Co., Ltd. Da Pin Jeong R&A Manager 250 Okgucheondong-Ro Siheung-City, Gyeonggido Republic of Korea 15084

Re: K180247

Trade/Device Name: DAEHAN Adhesive Surface Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 6, 2018 Received: August 10, 2018

Dear Da Pin Jeong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180247

Device Name DAEHAN Adhesive Surface Electrodes

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for DAEHAN MEDICAL SYSTEMS Co., Ltd. The logo is in blue and includes the company name. The image also includes the company's telephone and fax numbers: TEL: +82-31-432-6275, FAX: +82-31-432-6276.

Rev.2

250 Okgucheondong-Ro, Siheung-City, Gyeonggido, Republic of Korea, 15084

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

Dec. 22. 2017

2. Submitter's Information [21 CFR 807.92(a)(1)]

●	Name of Sponsor:	Daehan Medical Systems Co., Ltd.
-	Address:	250 Okgucheondong-Ro, Siheung-City, Gyeonggido,
		15084, Republic of Korea
●	Contact Name:	Da Pin Jeong / RA Manager
-	Telephone No.:	+82-31-432-6275
-	Fax No.:	+82-31-432-6276
-	Email Address:	dpjeong@dmsleadwire.com

Establishment Registration No.: . 3002893037
. Name of Manufacturer: Same as Sponsor . Address: Same as Sponsor

Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] 3.

. Trade Name: DAEHAN Adhesive Surface Electrodes
Regulation Name: Cutaneous electrode
Classification:

Classification Panel	Neurology
Classification Regulation	21 CFR 882.1320
Product Code	GXY
Device Class	II

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Image /page/4/Picture/0 description: The image shows the logo for DAEHAN MEDICAL SYSTEMS Co., Ltd. The logo is in blue and features the word "DAEHAN" in a stylized font. Below the word "DAEHAN" is the text "DAEHAN MEDICAL SYSTEMS Co., Ltd." in a smaller font. There is also a blue symbol above the word "DAEHAN".

250 Okgucheondong-Ro, Siheung-City, Gyeonggido, Republic of Korea, 15084

TEL: +82-31-432-6275 FAX: +82-31-432 Rev.2

Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] 4.

The identified predicate device within this submission is shown as follow;

510(k) Number: K073532 ●
●

Applicant:

Technomed Europe
Regulation Name: Cutaneous electrode
. Device Name: Disposable Adhesive Surface Electrodes

There are no significant differences between the DAEHAN Adhesive Surface Electrodes and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, and technical characteristics.

5. Description of the Device [21 CFR 807.92(a)(4)]

6. Intended Use [21 CFR 807.92(a)(5)]

The Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solidgel surface. The electrodes are non-sterile and for single patient use only.

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Image /page/5/Picture/0 description: The image shows the logo for DAEHAN MEDICAL SYSTEMS Co., Ltd. The word "DAEHAN" is written in a large, sans-serif font, with the letters connected to each other. Below the word "DAEHAN" is the text "DAEHAN MEDICAL SYSTEMS Co., Ltd." in a smaller font. There is a small graphic of a plus sign made of four smaller plus signs in the upper right corner of the logo.

250 Okgucheondong-Ro, Siheung-City, Gyeonggido, Republic of Korea, 15084

TEL: +82-31-432-6275, FAX: +82-31-432-6276 Rev.2

7. Technological Characteristics [21 CFR 807.92(a)(6)]

The DAEHAN Adhesive Surface Electrodes are based on a technical feature comparison, the proposed device was found to be similar to predicate device with regard to design, function, and technical characteristics.

	Proposed Device	Predicate Device
K Number		K073532
Model	DAEHAN Adhesive Surface Electrodes	Disposable Adhesive Surface Electrodes
Manufacturer	Daehan Medical Systems Co., Ltd.	Technomed Europe
Device Class	Class II	Class II
Product code	GXY	GXY
Intended Use	The DAEHAN Adhesive SurfaceElectrodes are intended for use withrecording, monitoring andstimulation equipment for the purposeof stimulating/recording ofbiopotential signals. Electrodesare applied in the study ofbiopotentials such asElectroencephalograph (EEG), surfaceElectromyography (EMG), nerveconduction and Evoked potentialsignals (EP). Electrodes arenon-invasive as they are applied to the,patient's skin using a self-adhesivesolid-gel surface. Theelectrodes are non-sterile and forsingle patient use only.	The Disposable Adhesive SurfaceElectrodes are intended for use withrecording, monitoring andstimulation equipment for the purposeof stimulating/recording ofbiopotential signals. Electrodesare applied in the study ofbiopotentials such asElectroencephalograph (EEG), surfaceElectromyography (EMG), nerveconduction and Evoked potentialsignals (EP). Electrodes arenon-invasive as they are applied to the,patient's skin using a self-adhesivesolid-gel surface. Theelectrodes are non-sterile and forsingle patient use only.
Anatomical sites	Surface	Surface
Patch Area	20 and 40*50mm	20 and 40*50mm
Patient population	Adult	Adult
Conductive surface area	12.56cm² and 20cm²	12.56cm² and 20cm²
Lead Wire Length	1.0 and 2.0m	1.0 and 2.0m
Construction electrode	Three layers1. Top sheet : Non woven Fabric2. Conductive film: Carbon film coated with silver chloride3. Conductive hydrogel	Three layers1. Top sheet : Non woven Fabric2. Conductive film: Carbon film coated with silver chloride3. Conductive hydrogel
Lead wire material	PVC insulated tin plated with copper	PVC insulated tin plated with copper
PH	3.5~7.0	6.5+/-0.5
Impedance	<3KΩ	<3KΩ
Ingredients	Polymerization and cross linking of monomer	Polymerization and cross linking of monomer
Maximum duration of use	2hour	2hour
Connectors	DIN 42 802 1.5mm and Touch proof connector	DIN 42 802 1.5mm and Touch proof connector
Sterilization Method	Non Sterilization	Non Sterilization

General Information

Cutaneous Electrode

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Image /page/6/Picture/0 description: The image shows the logo for DAEHAN MEDICAL SYSTEMS Co., Ltd. The logo is in blue and features the company name in a stylized font. Below the logo, contact information is provided, including the telephone number +82-31-432-6275 and fax number +82-31-432-6276. The image also includes the text "Rev.2".

250 Okgucheondong-Ro, Siheung-City, Gyeonggido, Republic of Korea, 15084

Non-Clinical Test Summary:

Biocompatibility 1)
- ISO 10993-5: Biological evaluation of medical devices Part 5: tests for in vitro ● cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices Part 10: tests for irritation and ● skin sensitization
1. Performance Testing
- Electrical property: AAMI/ANSI EC12 : Disposable ECG Electrodes .
1. Shelf-life Testing
- ASTM F1980-02, Standard guide for accelerated aging of sterile medical device package. ●
Basic Safety and Essential Performance 4)
- Electrical Safety: AAMI/ANSI ES 60601-1:2005/(R)2012, CL 8.5.2.3 : Patient Leads ●
- DAEHAN Adhesive Surface Electrodes were tested in accordance to the test requirements . and test methods of subclause 8.5.2.3 of IEC 60601-1:2005 and are in conformance with AAMI/ANSI ES 60601-1:2005. The differences between IEC 60601-1:2005 and AAMI/ANSI ES 60601-1:2005 do not alter the safety and effectiveness of DAEHAN Adhesive Surface Electrodes.

Substantial Equivalence [21 CFR 807.92b and 807.92] 8.

When compared to the predicate device (K073532), the DAEHAN Adhesive Surface Electrodes in this submission presented the substantial equivalence in terms of:

Intended use ●
Device design
Components and materials
Technological characteristics

Conclusion [21 CFR 807.92(b)(3)] 9.

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Daehan Medical Systems Co., Ltd., concludes that the DAEHAN Adhesive Surface Electrodes are substantially equivalent to predicate device as described herein.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).